The invention relates to a device for insertion into the human nose which is particularly suitable for the application of pharmaceutical active agents, for the exposure of diagnostic agents in the nose and for improving nasal breathing.
Obstructed nasal breathing can have a wide variety of causes. Congenital or acquired deformities in the osseous or cartilaginous nose structure, for example, can be the cause, as can chronic inflammatory or degenerative changes to the tissue.
The respiratory flow through the human body begins when air flows through the vestibule of the nose, or vestibulum nasi. Deformities in the nasal cartilage and inadequate elasticity in the structures of the connective tissue can lead to a constriction of the vestibulum nasi. Furthermore, during inhalation, it can happen that the wings of the nose are drawn in, leading to restricted nasal breathing. Since degenerative changes to the structures of the connective tissue are often responsible for the latter, this phenomenon occurs more often at a more advanced age and is not infrequently responsible for disturbing snoring noises.
In the case of the application for improving nasal breathing, the effect is to optimise the lumen situation in the region of the vestibulum nasi. For this purpose, the device, which may be shaped like a butterfly, is placed in the region of the vestibulum nasi in such a way that it dilates the nostrils or prevents the wings of the nose from being drawn in during inhalation and thus maintains or enlarges the internal diameter of the vestibulum nasi.
The nasal mucous membrane has good absorbent properties and is therefore in principle a good alternative route for applying pharmaceutical agents. Experiments have been conducted in applying both vaccines and various pharmaceutical agents via the nasal mucous membrane. It became apparent that problems in this connection were posed by the natural clearance system in the main nasal cavity. This system is capable of clearing substances applied to the nasal mucous membrane within an average of 10 minutes, i.e. transporting them towards the pharynx, from where the substances are then either expectorated or swallowed, which prevents adequate absorption.
Conventionally, in order to apply pharmaceutical agents in the main nasal cavity, presentations such as solutions or ointments are chosen. These presentations have the great disadvantage that they apply the pharmaceutical active agent in a kind of bolus. The consequence of this is firstly that the bolus is transported away quite quickly by the normal clearance behaviour of the nasal mucous membrane. Secondly, the massive short-term burden on the nasal mucous membrane stimulates the cleansing performance of the clearance apparatus, so that the rate of removal is increased still further. The consequence of this is that the pharmaceutical agents applied are often eliminated more quickly by mucociliary clearance than they can be absorbed.
Because of its proximity to and constant contact with the environment, the nasal mucous membrane is to a particularly high degree exposed to external irritations which not infrequently lead to hypersensitivity reactions and can even trigger pronounced allergies. Identifying the agent triggering the allergy is of great importance here, since it is only in this way that the causes can be treated in the form of avoidance of allergens or hyposensitisation. So far, intracutaneous tests or prick tests have been used for this purpose. These are in vivo test methods which test the body""s reaction to specific antigens in the skin of the lower arm or back. Their great disadvantage is that these test methods do not permit any statement to be made about the clinical relevance of their results because they do not provide any information concerning the acute processes taking place in the nose. These studies are therefore often used for screening purposes before subsequently carrying out a nasal provocation in a more targeted way. These studies are very sensitive and specific, but have the disadvantage that they can lead to powerful local reactions in the patient and that it is not possible to test a variety of allergens one immediately after the other.
In the context of a rhinitis allergica, for example, specific antibodies are raised against the antigen, the process occurring principally locally, at least at the beginning of the condition. Antibodies can therefore be found particularly in the nasal mucous membrane and in the nasal secretion.
The problem on which the invention is based consists in providing a device for insertion into the human nose which is suitable firstly for improving nasal breathing, i.e. which offers benefits in terms of its adaptability to different dimensions of the nasal vestibule and which also, where possible, creates a greater cross-sectional area for the flow of respiratory air; secondly, the device also forms a support or frame for therapeutic systems by which pharmaceutical active agents can be applied to the nasal mucous membrane in order for said agents then to be released in a delayed manner, or it is provided with diagnostic agents in order to be able to carry out different diagnostic reactions or tests in a simple way.
In accordance with the invention, this problem is solved by means of a device for insertion into the human nose which is characterised by having at least one elastically deformable plate-like base element with an inner side and an outer side and with a substantially rectangular shape, said element being substantially flat or slightly arched in its unstressed condition.
The base element can be designed in a slight butterfly shape, with two wings disposed symmetrically relative to a central line.
Laterally and/or at the top, the base element may be bevelled. The base element may be thicker in its central portion.
Provision can be made for the base element to possess a thread-like or rod-like extension for insertion and removal purposes.
The device can be made of a material suitable for remaining in the body cavity for a lengthy period, such as silicone rubber.
In a preferred embodiment, it is envisaged that the base element may be provided on the inner side and/or on the outer side with at least one pharmaceutical agent to be applied and/or at least one diagnostic agent.
In one embodiment of the device, it is envisaged that recesses may be provided on the inner side and/or on the outer side.
It is envisaged that platelets or sponges based on cellulose may be provided on the inner side and/or the outer side, or optionally in the recesses, as substrates for pharmaceutical agents and/or diagnostic agents. Alternatively, transmucosal and/or nasal therapeutic reservoir or matrix systems may be disposed inner side and/or outer side, or optionally in the recesses, as substrates for pharmaceutical agents and/or diagnostic agents.
In a preferred embodiment, it is envisaged that a second base element can be connected to the first base element via connecting means to form a single unit.
The invention also relates to the use of the device according to the invention for improving nasal breathing and/or for applying pharmaceutical agents and/or for exposing diagnostic agents in the nose.
When the invention is used for applying pharmaceutical agents, the latter can be applied to the device in a carrier layer or matrix on one or both sides, and their release can be adjusted as required either directly from the matrix or through a diffusion layer (membrane) disposed above it. In this way, it is possible to ensure that the pharmaceutical agents are released steadily in small doses, which increases their overall absorption rate. In addition, their use over any desired period makes it possible to achieve an even level of effective action over a defined period.
When the invention is used for exposing diagnostic agents, the corresponding substances, which are firmly bound to the device of the invention and can communicate with the environment, can be placed in the nasal vestibule for a period of approx. 20-30 minutes, for example. When the patient is suffering from an allergy, for example, an antigen positioned in this way can produce an antigen-antibody reaction which can later be detected by means of enzymatic or radiological immunoassays. With this method, it is thus possible to make a statement about the situation in the nasal mucous membrane at the time in question, without subjecting the patient to invasive measures or measures harmful to health. Furthermore, the method makes it possible to test various allergens simultaneously, because approx. 10 or more antigens can be applied to the device of the invention, which facilitates rapid diagnosis in a way that can be performed anywhere, including during everyday work in a doctor""s surgery. It goes without saying that the invention is not, however, restricted to the exposure of allergens; all diagnostic agents which can reasonably be used in the nasal region can be used.